The following data is part of a premarket notification filed by Keeler Ltd. with the FDA for Keeler Slit Lamp H-series.
| Device ID | K131589 |
| 510k Number | K131589 |
| Device Name: | KEELER SLIT LAMP H-SERIES |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KEELER LTD. CLEWER HILL RD. Windsor, Berkshire, GB Sl4 4aa |
| Contact | Nickie Power |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272715188 | K131589 | 000 |
| 05055272711555 | K131589 | 000 |
| 05055272711562 | K131589 | 000 |
| 05055272711579 | K131589 | 000 |
| 05055272711586 | K131589 | 000 |
| 05055272711593 | K131589 | 000 |
| 05055272711609 | K131589 | 000 |
| 05055272711630 | K131589 | 000 |
| 05055272711784 | K131589 | 000 |
| 05055272715157 | K131589 | 000 |
| 05055272711548 | K131589 | 000 |